FAMTX versus etoposide, doxorubicin, and cisplatin: A random assignment trial in gastric cancer Journal Article
| Authors: | Kelsen, D.; Atiq, O. T.; Saltz, L.; Niedzwiecki, D.; Ginn, D.; Chapman, D.; Heelan, R.; Lightdale, C.; Vinciguerra, V.; Brennan, M. |
| Article Title: | FAMTX versus etoposide, doxorubicin, and cisplatin: A random assignment trial in gastric cancer |
| Abstract: | Purpose: The chemotherapy regimens of high-dose methotrexate, high-dose fluorouracil (FU), Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and leucovorin (FAMTX) and etoposide, Adriamycin, and cisplatin (EAP) have both been reported in nonrandom assignment trials to have high overall response rates and substantial complete response rates in patients with gastric cancer, as well as major toxicities of myelosuppression. Here we report a prospective, stratified, random-assignment comparison of the two combinations in previously untreated patients with advanced gastric cancer. Patients and Methods: Sixty patients were entered onto the trial, 30 receiving EAP and 30 FAMTX. All patients had measurable or assessable tumor masses. Patient entry was stopped at the point when significant toxicity differences were seen at interim analysis. Results: Response rates were similar between the two arms (FAMTX, 33% [95% confidence interval (CI), 16% to 50%]; EAP, 20% [95% CI, 6% to 34%]). Three FAMTX and no EAP patients had complete remissions. The median survival for the two arms were similar (EAP, 6.1 months; FAMTX, 7.3 months). At 1 year, 7% of EAP and 17% of FAMTX patients were alive. EAP caused significantly more myelosuppression (leukopenia, P = .002; anemia, P = .03; thrombocytopenia, P = .0001) than did FAMTX. EAP also resulted in significantly longer hospitalizations per study month (8 v 5 days). Four EAP patients died of lethal toxicity, whereas no FAMTX patients died of treatment-related causes (P = .04). Conclusions: FAMTX is at least as active as EAP and is significantly less toxic. Although both regimens remain investigational, the toxicities of FAMTX are more manageable. Further studies involving FAMTX in both the adjuvant and advanced disease setting are underway. © 1992 by American Society of Clinical Oncology. |
| Keywords: | adult; cancer survival; aged; survival analysis; major clinical study; cancer localization; cisplatin; doxorubicin; fluorouracil; advanced cancer; cancer combination chemotherapy; drug efficacy; drug safety; conference paper; comparative study; combined modality therapy; methotrexate; laparotomy; prospective studies; nephrotoxicity; bone marrow suppression; etoposide; gastrointestinal symptom; antineoplastic combined chemotherapy protocols; drug fatality; cancer regression; folinic acid; stomach cancer; randomization; leucovorin; stomach neoplasms; oral drug administration; middle age; bone marrow diseases; human; male; female; priority journal; support, u.s. gov't, p.h.s. |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 10 |
| Issue: | 4 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 1992-04-01 |
| Start Page: | 541 |
| End Page: | 548 |
| Language: | English |
| DOI: | 10.1200/jco.1992.10.4.541 |
| PUBMED: | 1548519 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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